Source: FDA, document on fileFDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it.
To check this against FDA, open FDA's record for this establishment on FDA's Data Dashboard, which lists this inspection under FEI 3003434972.
Wedgewood Connect, LLC
San Jose, California, United States
Issue DateJune 15, 2017
FEI Number3003434972
CountryUnited States
Status
No Warning Letter
Product Type
Outsourcing Facility
Establishment Type
Outsourcing Facility
Sub Systems Impacted
2
Contamination ControlInvestigations
Quality Systems
Quality SystemFacilities & Equipment
Wedgewood Connect, LLC FDA Form 483, San Jose, California, June 15, 2017